Subtitle Text HereZylon Medical Devices

Smaller Is Better

Supported by NIH SBIR PHASE II Grant # 5 R44 H 68331-3

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Angioplasty

Catheter Featuring

The “ZeroFold” Balloon

Overview

The Zylon® Angioplasty catheter with “ZeroFold” Balloon

Innovative cardiovascular deviceDeveloped to expand clinical application of percutaneous transluminal coronary angioplasty (PTCA)Based on patented technologyAngioplasty balloon catheter with “absolutely the lowest profile”Allows certain previously un-crossable or difficult-to-cross stenosed coronary arteries to be crossable and dilatable with efficacy and precision

Supported by NIH SBIR Phase II Grant # 5 R44 H 68331-3

The Problem

PTCA

Percutaneous Transluminal Coronary Angioplasty (PTCA)

Minimally invasive surgical approachFor treatment of coronary artery blockages

Stenosed artery

Current Catheters

Current Balloon CathetersAs typically used in PTCA procedures

Balloon is pre-sized, folded, wrapped and located at end of catheterCatheter is placed across a stenotic lesionUpon presserization, balloon unfolds to force open the stenosis

Crossing the Lesion

Crossing the LesionPhysician must be able to cross the lesion to dilate the stenosisAny increase in crossing resistance restricts clinical usefulness, especially in these procedures:

Small arteriesTight stenosesChronic Total Occlusion (CTO)

Surgery

Inability to Cross LesionConsigns patient to open heart surgery

Open heart surgery is effective, but characterized by:High morbidityHigh ExpenseLong recovery times

The Preferred treatment is the minimally invasive balloon angioplasty procedure

The Problem

Reducing the profile of the balloon in PTCA catheters

still remains clinically significant in interventional cardiology.

The Zylon® Solution

The Zylon® Solution

The Zylon® PTCA Catheter with ZeroFold Balloon

Based on patented technologyUtilizes a non folded balloonInflates to full size after crossing target stenosisEliminates the folded and wrapped balloon of current angioplasty catheters

The Zylon® Solution

Standard Catheter and BalloonFull size balloon attached to catheter shaftThen wrapped and folded to reduce profileCreates region of high cross resistance due to presence of multiple layers of wrapped and folded balloon material

The Zylon® Solution

Zylon® Catheter with Zero Fold Balloon

Balloon has NO wrapped or folded materialExhibits smooth, continuous transition from tip to proximal shaft“Absolutely the lowest profile” possible

The Zylon® Solution

InflationZylon® “ZeroFold” balloons inflate with predictable radial expansion characteristicsHigh burst strengthHigh flexibilityLow axial growth

The Zylon® Solution

Zylon® “ZeroFold” balloon vs. standard folded balloon

Zylon No-FoldBalloon Catheter

ConventionalBalloon Catheter

No FoldBalloon

FoldedBalloon

Inner Lumen

The Zylon Solution

Upper Catheter0.024” Hole Test

Fail- at distal fold

Zylon Catheter0.024” Hole Test

Pass- entire balloon

The Zylon Solution

Other advantagesImproved Pushability

Easier crossing, less resistance

FlexibleSmooth gentle inflationEasier to manufactureSimple, no retraining requiredSmaller* profile over entire range of coronary balloon catheter sizes (1.5-4.0*)

The Zylon Solution

ApplicationsCTO Pre-dilationPOBA (plain old balloon angioplasty)Stent delivery – lower profile with custom stentRx, over-the-wire, fixed wire versions

Intellectual Property

Intellectual Property

The following patents and patent applications have relevance to ZeroFold balloon technology:

US 5,900,444, Irradiation Conversion of Thermoplastic to Thermoset Polyurethane.US 6,596,818, Irradiation Conversion of Thermoplastic to Thermoset Polymers. US 6,558,732, Process for producing and implantable apparatus comprising a biomedical device coated with cross-linked TPU.US 6,656,550, Dilatation device of uniform outer diameter.EP 0934007, Irradiation Conversion of Thermoplastic to Thermoset Polymers.Canada 2,267,684, Irradiation Conversion of Thermoplastic to Thermoset Polymers.IS129342, Irradiation Conversion of Thermoplastic to Thermoset Polymers.US 20030212318, Process for producing and implantable apparatus comprising a biomedical device coated with cross-linked TPU.US 20040002729, Irradiation Conversion of Thermoplastic to Thermoset Polymers. US 20040093008, Reduced Profile Medical Balloon Element.

Intellectual Property

Trademarks

Zylon, US 2,174,478

Penetrator US 77315423

Irracure US 2,574,588

Fluorothane US 2,505,088

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Zylon Corporation600 Chestnut Ridge RoadChestnut Ridge, NY 10977

845-425-9469sales@zylon.com